B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com.
Responsibilities: Essential Duties
Perform laboratory testing related to product release in accordance with FDA and ISO guidelines,
Follow internal policies, standards, and procedures relating to their job specific duties,
Training to current practices and be skills assessed on those practices,
Interface with cross functional teams and ensure positive working relations in a professional manner,
Perform activities required for the execution of the laboratory test methods;
Maintain laboratory equipment cleaning and servicing;
Tracking and communication on laboratory inventory of supplies;
Perform GxP and general laboratory functions as required;
Performs data entry in various formats, as required, to support departmental needs.
Support departmental goals and objectives by contributing on continuous improvement initiatives.
Adhere to all safety and laboratory rules.
Operate in accordance with company policies and procedures, FDA Regulations, ISO Standards, USP, NF, and Canadian Medical Device Regulations where applicable.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time. General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.
Expertise: Knowledge & Skills
Chemistry knowledge and skills as it pertains to a GxP laboratory;
LAL knowledge and skills as it pertains to a GxP Laboratory;
Stability knowledge and skills as it pertains to a GxP Laboratory;
Microbiology knowledge and skills as it pertains to a GxP Laboratory.
Moderate understanding of Lab theories and practices;
Moderate understanding of Data Compilation Techniques;
Efficient use of laboratory Electronic Measuring Devices and Scientific Instrumentation;
Moderate understanding of scientific writing, and oral presentation;
Moderate understanding of mechanical aptitude towards equipment;
Moderate understanding of operational excellent principles;
Able to be organized, meet timelines, and communicate effectively;
Able to show initiative and work independently as well as with a team;
Able to interpret scientific data and draw conclusions based on the data;
Daily use of computer programs including Word, Excel, Outlook;
Must be well organized / detail-oriented to meet deadlines.
Have the ability to prepare, process, and file documents.
Must have people skills, writing, and oral presentation skills.
Supervision Given and Received:
Works under general supervision.
May periodically assist in orienting, training, assigning and checking the work of peers.
BS degree from a four year college in a science discipline, with a minimum of 3 years related experience or equivalent combination of education and experience as a Laboratory Associate.
Must have some experience in QA/QC, FDA, ISO, OSHA, GLP, cGxP, and QSR,
5 years experience in the biological or chemical sciences.
Completed required Internal Training and passed required assessments.
QA / QC / QE / QSR / GMP / ISO / FDA Training.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.
Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.